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Aviptadil

CEO Update
Nov. 22, 2021
CEO Update: Denial of Breakthrough Therapy Designation

The US Food and Drug Administration (FDA) denied NRx Pharmaceuticals’ (NRx) request for Breakthrough Therapy Designation (BTD) for ZYESAMI® (aviptadil). BTD is not required for drug approval or emergency use authorization, but can afford faster review times, the ability to submit a rolling application, and dedicated FDA review personnel who may interact more frequently with […]

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NRx Press Release
Nov. 12, 2021
NRx Pharmaceutical’s Chairman and Chief Executive Officer Jonathan Javitt to Present Company Business Update at H.C. Wainwright 7th Annual Israel Conference

Conference Begins on November 15, 2021 RADNOR, Pa., Nov. 12, 2021 (GLOBE NEWSWIRE) — NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage, biopharmaceutical company, today announced its Chairman of the Board and Chief Executive Officer, Jonathan Javitt, will be presenting updates to the Company’s business at the H.C. Wainwright 7th Annual Israel Virtual Conference. Details of the presentation can […]

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NRx Press Release
Nov. 11, 2021
NRx Pharmaceuticals Receives US Food and Drug Administration Review of ZYESAMI® (aviptadil) Manufacturing Information

US Food and Drug Administration Review Allows for High Volume Production of ZYESAMI® (aviptadil) Shelf Life of ZYESAMI Now Extended from 62 Days to 150 Days RADNOR, Pa., Nov. 11, 2021 (GLOBE NEWSWIRE) — NRx Pharmaceuticals (NASDAQ: NRXP), today announced receipt of the US Food and Drug Administration’s (FDA) response to NRx’s October 8 submission of […]

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Nov. 8, 2021
CEO Update: ZYESAMI® (aviptadil) Next Steps

I recently received the letter below from a shareholder. The correspondence from them (taken exactly from their email) and my response regarding our next steps for ZYESAMI ® (aviptadil) can be found below. Email from R.B., a shareholder of NRx Pharmaceuticals Dear Dr. Javitt I have been heartbroken since the denied emergency approval for Zyesami/Aviptadil. […]

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Nov. 2, 2021
NRx Pharmaceuticals Announces Favorable, New Safety Report for ZYESAMI® (aviptadil) in NIH Sponsored ACTIV-3b Critical Care Study in Patients with Life-Threatening COVID-19

After Review of More than 300 Enrolled Patients in ACTIV-3b Critical Care Study, No New Safety Concerns Raised by Independent Data Safety Monitoring Board; Study Cleared to Continue Enrollment to Target 640 Patients ACTIV-3b Critical Care Study is Evaluating ZYESAMI® (aviptadil) and Remdesivir, in Critical COVID-19 Patients, as Monotherapy and in Combination Against Placebo ACTIV-3b […]

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Oct. 25, 2021
CEO Update: Nation of Georgia Emergency Use Authorization

We have received several questions about the status of the Emergency Use Authorization granted to aviptadil in the Nation of Georgia.  Attached please find a copy of the official notification from the Regulation Agency for Medical and Pharmaceutical Activities of the Nation of Georgia, that states as follows: 06 August 2021 Georgian Respiratory Association to […]

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Oct. 25, 2021
CEO Update: Breakthrough Therapy Designation

Recently, we’ve received several questions about the Breakthrough Therapy Designation (BTD) application NRx submitted to the US Food and Drug Administration (FDA) for ZYESAMI™ (aviptadil) last month. As you know, we received BTD for our psychiatry drug NRX-101 for suicidal bipolar depression. Admission to the BTD program provided us with increased access to review guidance […]

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Oct. 14, 2021
Journal of Infectious Diseases and Treatment Publishes Positive Trial Data of Aviptadil in High Comorbidity Patients Suffering from Critical COVID-19 with Respiratory Failure

Seventeen of 21 Patients Treated with Aviptadil Survived to Day 60 Compared to 5 of 24 in the Controlled Group of Patients RADNOR, Pa., Oct. 14, 2021 /PRNewswire/ — NRx Pharmaceuticals (Nasdaq: NRXP), today announced the publication of peer-reviewed results from a prospective, open-label, administratively controlled trial of aviptadil for the treatment of respiratory failure in patients with Critical COVID-19. […]

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